Essential best practices for the prevention
of surgical site infection
in developing countries
Benedetta Allegranzi
Lead, Clean Care is Safer Care,
WHO Service Delivery and Safety, HQ
Faculty of Medicine, University of Geneva,
Geneva, Switzerland
ICAN Conference, 4 November 2014, Harare Zimbabwe
SSI prevention is complex…
2014
Recommendations…
In the 1999 CDC guideline, there are 65
recommendations to control SSI
In the new CDC draft guidelines, there are
30 research questions
For the new WHO guidelines, there are 22
topics undergoing systematic review
SSI prevention guidelines – WHO perspectives
Lessons learned from the WHO HH guidelines:
need for global approach
Valid for any country, but including specific issues
depending on regional differences and/or peculiar
to low-/middle-income countries
Strong component on implementation
strategies and surveillance
Associated implementation tools
Lessons learned from checklists and other
programmes
Key Elements in Reducing SSI
Courtesy by J. Solomkin
Surgical Care Improvement Project (SCIP)*
• SCIP INF 1: Prophylactic antibiotic received within one hour prior to surgical incision
• SCIP INF 2: Prophylactic antibiotic selection for surgical patients
• SCIP INF 3: Prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients)
• SCIP INF 4: Cardiac surgery patients with controlled 6 a.m. postoperative serum glucose
• SCIP INF 6: Surgery patients with appropriate hair removal (retired)
• SCIP INF 7: Colorectal surgery patients with immediate postoperative normothermia
*USA, 2002-present
Goal: to reduce SSI by 25% by the year 2010
Munday GS, et al. The American Journal of Surgery, 2014
http://dx.doi.org/10.1016/j.amjsurg.2014.05.005
Impact of SCIP
(A) odds ratio of SSI and (B) percentage change in SSI
18% decrease in the odds of developing SSI
and a cumulative 4% decrease in SSI
METHODS
Prospective quasi experimental cohort study
4-year (2008-2011) SSI prospective surveillance of colorectal surgery with the introduction of bundle for SSI prevention
Bundle: 1) perioperative antibiotic prophylaxis; 2) hair removal before surgery 3) perioperative normothermia; 4) discipline in the operating room
1537 surgical interventions
RESULTS
SSI decrease over time (borderline significant)
Significant SSI decrease (36%) in 2010/2011 after adjustment for confounders
SSI patients had a higher likelihood to die within 6 m (Logistic regression analysis)
Bundle compliance increase from introduction in 2009 10% to 2011 80% (p< 0.01)
METHODS
34-month, single-institution, blinded randomized controlled trial
211 pts undergoing elective trans-abdominal colorectal surgery included, 197 in
ITT analysis
Intervention: (1) omission of mechanical bowel preparation; (2) preoperative and
intraoperative warming; (3) supplemental oxygen during and immediately after
surgery; (4) intraoperative intravenous fluid restriction; (5) use of a surgical wound
protector
RESULTS
SSI overall rate 45% vs 24% in the intervention vs standard arm (P=.003)
Main difference was in superficial SSI rate (36% vs 19%, p<0.04)
Allocation to the standard arm independent RF for SSI (2.49-fold risk; 95% CI,
1.36-4.56, P=.003)
Compliance with the bundle: 99% of subjects received at least 4 of 5 of the bundle
interventions. Complete compliance with all of the 5 interventions was 84%
Systematic review on HAI prevention in LMIC -Studies on SSI prevention
Total: 84 (infection type most frequently addressed)
59 studies in which the intervention is ANTIMICROBIAL
PROPHYLAXIS only
25 studies in which other type IP interventions are included:
6 Surgical technique
5 Post-surgery wound management
3 Skin or surgical site preparation
3 Hand hygiene
2 ATB impregnated materials
2 Multimodal/checklist
1 Guidelines implementation
1 Surveillance and feedback
1 Mechanical bowel preparation
1 Anesthesia J. Hopman, B. Allegranzi et al. ICPIC 2013
Global perspective on SSI
http://www.who.int/patientsafety/safesurgery/en/
Haynes et al. NEJM 2009; 360:491-9.
London, UK
EURO EMRO
WPRO I
SEARO
AFRO
PAHO I
Amman, JordanToronto, Canada
New Delhi, India
Manila, Philippines
Ifakara, Tanzania
WPRO II
Auckland, NZ
PAHO II
Seattle, USA
The Checklist was piloted in 8 cities…
Results – All Sites
Baseline Checklist P
value
Cases 3733 3955 -
Death* 1.5% 0.8% 0.003
Any Complication** 11.0% 7.0% <0.001
SSI 6.2% 3.4% <0.001
Unplanned
Reoperation
2.4% 1.8% 0.047
*Significant death rate reduction only in low/middle-income countries (p=0.006)
**Significant complication rate reduction in both high-income and low/middle-income countries
Haynes et al. New England Journal of Medicine 2009; 360:491-9.
Changes in safety attitudes following the checklist implementation• Before/after survey
• Modified Safety Attitudes Questionnaire (SAQ)
• 7 sites Haynes et al. BMJ Qual Saf 2011;20:102e107
Degree of improvement of mean SAQ score correlated with a reduction in
postoperative complication rates (R=0.7143, p=0.0381)
Implementation and use of the checklist is a cost saving quality improvement strategy.
Vats A et al. BMJ 2010
+
Patient safety climate improvement (CUSP):
• Science of safety education
• Staff safety assessment
• Leadership
• Learning from defects
• Team work & communications
Infection prevention & control
Best practices
Safe Surgery Checklist
Improvement of the patient
safety climate
+
Surgical Unit-based Safety Programme (SUSP)
Reduction of:
Surgical site infections
Surgical complications
The Vision of CUSP
The Comprehensive Unit-based Safety Program
(CUSP) is designed to:
– Improve patient safety awareness and systems thinking at the unit level
– Mobilize staff to identify and resolve patient safety issues
– Create a patient safety partnership between executives and frontline caregivers
– Provide tools to help CUSP teams investigate and learn from defects and improve teamwork and safety culture
SUSP pilot study
Before/after study in colorectal surgery
Intervention: CUSP + standardization of skin preparation;
administration of preoperative chlorhexidine showers;
selective elimination of mechanical bowel preparation;
warming of patients in the preanesthesia area;
adoption of enhanced sterile techniques for skin and fascial closure;
addressing previously unrecognized lapses in antibiotic prophylaxis.
Results: mean SSI rate decrease (from 27.3% to
18.2%), 33.3% (95% CI, 9–58%; p=0.05)
Wick EC, et al. J Am Coll Surg 2012
Technical versus Adaptive
Technical
• Specific actions
• Protocols
• Procedures
WHAT WE DO
Adaptive
• Behaviours
• Attitudes
• Values
• Beliefs
HOW WE DO IT
Safety culture
• Risk is acknowledged by the organisation, incl SSI
• Non-punitive approach to incidents
• Collaboration across the ranks
• Resources are allocated to safety
• Ultimate aim to make safety an integral part of
everything we do
Tools for adaptive work
• Science of safety video
• Hospital survey of patient safety
• Executive engagement and walk around
• Staff safety assessment
• Barrier identification and mitigation
• Learning from defects
KIJABE HOSPITAL, KENYA
HSOPS results: “Mistakes blamed on an individual”
Page 27
HSOPS results
• “Staff suffer in silence for fear of victimization if they voice
concerns”
• “Many staff feel incident reports are for intimidation and
victimization because those who write go through that”
• “Leaders do not have time to listen to us but blame us”
• “Ward meetings should be held regularly for an improved
patient care”
• “Resource constraints limit effective system optimization
for patient safety and reporting of adverse events”
• “There is need for a well- organised system of monitoring
patient safety issues and reporting, analyzing and
feedback of events or errors”Page 28
Identify at least one actionable idea to
improve unit results in this area
• Create a culture to build trust between the senior
and the front line staff
• Organize focus groups for leaders to reflect on
the concepts of "leadership" and "followership"
(challenge them to understand what type of
leaders they are)
• Include concepts on "leadership" and
"followership" in the safety culture presentations
• Organize events and use opportunities to
effectively create the team work and spirit
An actual case at Kijabe...
SSI prevention activities –Infection control measures
• Patient pre-operative bathing
• Hair removal (not necessary or with clippers)
• Optimization of surgical site skin preparation
• Optimization of surgical hand preparation
• Optimization of surgical antibiotic prophylaxis
(timing, dose, type of ATB, re-dosing)
• Discipline in the OR (limiting number of people
and door opening during operation)
33
Available tools
• Set of updated presentations (main topics:
science of safety, epidemiology of SSI,
interventions to reduce SSI)
• Updated Fact Sheets
• Poster on SUSP IPC measures
• Pocket leaflet
• Poster on handrubbing technique
SUSP tools and WHO checklist
Page 35
Pocket leaflet
Intervention phase
Printed learning materials... ... and training sessions
Patient preparation for surgery
Intervention steps
1. Pre-operative bathing (bath or shower)
• Use soap, ideally antimicrobial soap
• Ideally 1-2 hours before the operation
CDC 2013 - Require patients to shower or bathe (full body)
with either soap (antimicrobial or non-antimicrobial)
or an antiseptic agent on at least
the night before the operative day (Category IB)
Preoperative bathing or
showering with skin antiseptics
to prevent surgical site infection
Webster J, Cochrane DSR 2012
1. Patient pre-operative bathing
Challenges Interventions
Cost Sourced for fair priced soap
Patient acceptability to change soap Did a survey for tolerability to new soap.
Well received by patients
Bathing times not linked to time of
surgery.
SOP created and nurses educated
Nurses fetching hot water for bedside
bathing
Instant showers to lessen work
Example 1 of Kijabe approach to “technical” elements of
SUSP intervention – identifying problems +solutions
Antiseptic soap survey
Discipline in the OR
1. Use adequate attire and maximum asepsis
2. Organization & planning: make sure that all the
equipment needed is in the OR before starting
3. Limit the number of people in the OR to those
essential to the operation only
4. If students, limit the number and make sure they
are trained according to the asepsis rules
5. Keep door and windows closed during the
operationPage 43
6. Discipline in the OR - limiting number of people and door opening during operationsChallenges
Too many door openings during cases Posters and barrier notices
Staff education
Phones in every theater room for
communication to avoid unnecessary
movement
Standardized protocols/equipment for
every case.
Carry out internal survey
Example 2 of Kijabe approach to “technical” elements of
SUSP intervention – identifying problems +solutions
Antibiotic prophylaxis – best practices
• Protocols according to most frequent pathogens and
ideally, local resistance patterns
• Correct pre-operative administration timing: 60 minutes
before surgical incision.
• Correct antibiotic type according to the procedure and
patient history (of allergy or severe adverse events)
• Correct dose and intraoperative redosing:
Standardized doses should be used
Increased doses based on patient weight
According to the antibiotic type, doses should be repeated
during the operation at specific time intervals (see table) if the
duration of the procedure is prolonged or if excessive
blood loss (e.g., >1500 mL) or extensive burns.
• Appropriate discontinuation after surgery: single dose or
duration of less than 24 hours.
Page 48
Procedure Drug/dosing pre-operatively Alternative drug for history of
anaphylactic reactions
Recommended re-dosing interval, hours
Colorectal Cefazolin* 2 g (3g for pts
weighing > 120kg) +
metronidazole 500 mg OR
Cefotetan 2 g OR
Cefoxitin 1g
Ciprofloxacin 400 mg +
metronidazole 500 mg
Cefazolin, 4
Metronidazole, not needed, unless operation >8 hrs
Cefotetan, 6
Cefoxitin, 2
Ciprofloxacin, not needed, unless operation >7 hrs
High-risk gastro-duodenal and biliary Cefazolin 2 g (3g for pts
weighing > 120kg)
Ciprofloxacin 400 mg Cefazolin, 4
Ciprofloxacin, not needed, unless operation >7 hrs
Breast Cefazolin 2 g (3g for pts
weighing > 120kg)
Clindamycin 900 mg or
Vancomycin 15 mg/kg
Cefazolin, 4
Clindamycin, 6
Vancomycin, not needed, unless operation >8 hrs
Orthopedic – (total joint replacement,
closed fractures / use of nails, bone
plates, other internal fixation devices,
functional repair without implant
/devices, trauma)
Cefazolin 2 g (3g for pts
weighing > 120kg)
Gentamicin 5 mg/kg +
Clindamycin 900 mg
Cefazolin, 4
Gentamicin, not needed, unless operation >8 hrs
Clindamycin 6
Noncardiac thoracic – thoracic
(lobectomy, pneumonectomy, wedge
resection, other noncardiac
mediastinal procedures), closed tube
thoracostomy
Cefazolin 2 g (3g for pts
weighing > 120kg)
Clindamycin 900mg Cefazolin, 4
Clindamycin, 6
Appendectomy
(prophylaxis needed only in
complicated or suppurative cases)
Cefazolin 2 g (3g for pts
weighing > 120kg) +
metronidazole 500 mg OR
Cefotetan 2g OR
Cefoxitin 2g
Ciprofloxacin 400 mg +
Metronidazole 500 mg
Cefazolin, 4
Metronidazole, not needed, unless operation >8 hrs
Cefotetan, 6
Cefoxitin, 2
Ciprofloxacin, not needed, unless operation >7 hrs
Obstetric and gynecologic Cefazolin 2 g (3g for pts
weighing > 120kg)
Ciprofloxacin 400 mg +
Metronidazole 500mg
Cefazolin, 4
Metronidazole, not needed, unless operation >8 hrs
Ciprofloxacin, not needed, unless operation >7 hrs
Urologic (may not be beneficial if urine
is sterile)
Cefazolin 2 g (3g for pts
weighing > 120kg)
Ciprofloxacin 400 mg +
Metronidazole 500mg
Cefazolin, 4
Metronidazole, not needed, unless operation >8 hrs
Ciprofloxacin, not needed, unless operation >7 hrs
Cardiac surgery Cefazolin 2 g (3g for pts
weighing > 120kg)
Clindamycin 900mg Cefazolin, 4
Clindamycin, 6
Page 49
Procedure Antibiotic Prophylaxis RecommendationHEAD AND NECK (INTRACRANIAL)
Craniotomy A Antibiotic prophylaxis is recommended
Cerebrospinal Fluid (CSF) Shunt A Antibiotic prophylaxis is recommended
Spinal surgery A Antibiotic prophylaxis is recommended
HEAD AND NECK (OTHER)
Head, facial or neck surgery (clean, benign) D Antibiotic prophylaxis is not recommended
Head and neck surgery (clean, malignant;
neck dissection)
C Antibiotic prophylaxis should be considered
Head and neck surgery (contaminated/clean-
contaminated)
A Antibiotic prophylaxis is recommended
The duration of prophylactic antibiotics should not be more
than 24 hours
Ensured broad spectrum antimicrobial cover for aerobic
and anaerobic organisms
C
D
THORAX
Breast cancer surgery A Antibiotic prophylaxis should be considered
Open heart surgery C Antibiotic prophylaxis is recommended
The duration of prophylactic antibiotics should not be more
than 48 hours
C
Pulmonary Resection A Antibiotic prophylaxis is recommended
Etc…
Operation Group Antibiotics for PROPHYLAXIS Dose Timing
General Surgery “abdominal”
(eg laparotomy, appendisectomy (if no perforation), biliary tract
surgery, colorectal surgery, gastroenteric surgery
Ampicillin 2g
Flagyl 500mg
Single pre-op dose,
no post-operative antibiotics
General Surgery “non-abdominal”
(eg hernia repair, mastectomy, thyroidectomy, plastic surgery, burns
grafting , fasciotomy, cardiothoracic and vascular surgery, )
Ampicillin 2g Single pre-op dose,
no post-operative antibiotics
CLEAN Orthopaedic surgery
(eg ORIF, craniotomy, interlocking nail)
Ceftriaxone 2g Single pre-op dose,
no post-operative antibiotics
ANY Contaminated or Dirty/Infected operation
Including
Surgical Toilet, Abscess drainage, arthrotomy for septic arthritis,
traumatic wound closure, any gastro-intestinal perforation,
amputation for gangrene.
Any patient with an infection at the time of surgery (eg
chorioamnionitis, infected wound, abscess).
Ampicillin 2g
Flagyl 500mg
Pre-operative PROPHYLAXIS AND then
to received TREATMENT after
operation as per clinicians
prescription.
Patient with reported allergy to penicillin, for any surgery
*Note: there is a small risk of cross-allergy between Penicillins and
Cephalosporins (approx 10% risk)
Omit Ampicillin from AP if
good history of allergy. Can use
Ceftriaxone* (2g) instead if
necessary.
Single pre-op dose,
no post-operative antibiotics
Initial SAP protocol
Page 52
Operation Group Antibiotics for PROPHYLAXIS Dose Timing
General Surgery “abdominal”
(eg laparotomy, appendisectomy (if no perforation), biliary tract
surgery, colorectal surgery, gastroenteric surgery
Ampicillin 2g
Flagyl 500mg
Single pre-op dose,
no post-operative antibiotics
General Surgery “non-abdominal”
(eg hernia repair, mastectomy, thyroidectomy, plastic surgery, burns
grafting , fasciotomy, cardiothoracic and vascular surgery, )
Ampicillin 2g Single pre-op dose,
no post-operative antibiotics
CLEAN Orthopaedic surgery
(eg ORIF, craniotomy, interlocking nail)
Ceftriaxone 2g Single pre-op dose,
no post-operative antibiotics
ANY Contaminated or Dirty/Infected operation
Including
Surgical Toilet, Abscess drainage, arthrotomy for septic arthritis,
traumatic wound closure, any gastro-intestinal perforation,
amputation for gangrene.
Any patient with an infection at the time of surgery (eg
chorioamnionitis, infected wound, abscess).
Ampicillin 2g
Flagyl 500mg
Pre-operative PROPHYLAXIS AND then
to received TREATMENT after
operation as per clinicians
prescription.
Patient with reported allergy to penicillin, for any surgery
*Note: there is a small risk of cross-allergy between Penicillins and
Cephalosporins (approx 10% risk)
Omit Ampicillin from AP if
good history of allergy. Can use
Ceftriaxone* (2g) instead if
necessary.
Single pre-op dose,
no post-operative antibiotics
Initial SAP protocol
Page 54
Operation Group Antibiotics for
PROPHYLAXIS
Second option Dose Timing
General Surgery “abdominal”
(eg laparotomy, appendectomy (if
no perforation), biliary tract
surgery, colorectal surgery,
gastroenteric surgery
Cloxacillin 2 g
+
Gentamicin 5mg/kg
+
Metronidazole 500 mg
Penicillin G dose 4 MU
+ Gentamicin 5mg/kg +
Metronidazole 500 mg
Single pre-op dose.
No post-operative antibiotics,
repeat Cloxacillin if > 4h intervention
duration.
Metronidazole and Gentamicin, no need
to repeat, unless operation >8 h
General Surgery “non-abdominal”
(eg hernia repair, mastectomy,
thyroidectomy, plastic surgery,
burns grafting , fasciotomy
Cloxacillin 2 g
+ Gentamicin 5mg/kg
Single pre-op dose,
no post-operative antibiotics,
repeat Cloxacillin if > 4h intervention
duration.
Cardiothoracic and vascular
surgery
Chloramphenicol 1 g Vancomycin 15 mg/kg Single pre-op dose,
no post-operative antibiotics,
repeat Chloramphenicol if > 4h and
Vancomycin if >8h intervention duration.
CLEAN Orthopaedic surgery
(eg ORIF, craniotomy, interlocking
nail)
Gentamicin 5 mg/kg +
Clindamycin 900 mg
Vancomycin 15 mg/kg Single pre-op dose,
no post-operative antibiotics,
repeat Clindamycin if > 6h and
Vancomycin if >8h intervention duration.
ANY Contaminated or
Dirty/Infected operation
Cloxacillin 2 g X 6 times a day
or 12 g in 500 cc continuous
perfusion (over 24hrs) +
Gentamicin 5mg/kg once daily
for 5 days + Metronidazole 500
mg X times a day
For severe cases -
Imipenem 4x500mg
Single dose pre-operative
PROPHYLAXIS and then TREATMENT
after operation.
Antibiotic prophylaxisIs it possible to get to 100% of patients getting
- Right DRUG+DOSE
- Right TIME
- Right DURATION
in an African Hospital ?
0%
20%
40%
60%
80%
100%
% o
f opera
tions g
iven p
rophyla
xis
% given PRE-op prophylaxis
% given POST-op antibiotics
AP Policy
introduced
Feb 2011
Thika Hospital, Kenya, 2010-2011, Aiken et al, PLOS ONE 2013
SSI : Overview of existing guidelines
SKIN PREPARATIONUK High impact intervention bundle
(March 2011)
2% Chlorhexidine gluconate (CHG) in 70 % isopropyl alcohol solution;
povidone-iodine with alcohol for patients who are allergic to
Chlorhexidine
USA Institute of Health Improvement
Surgical Site Infection (Jan 2012)
None
USA Institute of Health Improvement
Hip & knee arthroplasty (Nov. 2012)
Combination either an iodophor or CHG with alcohol is better than
povidone-iodine alone
Scottish Health Protection bundle
(Oct 2013)
2% CHG in 70 % isopropyl alcohol
solution; povidone-iodine with alcohol for patients who are allergic to
CHG
Ireland : Royal College of
Physicians (2012)
1A
2% CHG in 70 % isopropyl alcohol solution; povidone-iodine with alcohol
for patients who are allergic to CHG
NICE
(June 2013)
Povidone-iodine or chlorhexidine, though alcohol-based solutions may
be more effective than aqueous solutions. Most effective antiseptic for
skin preparation before surgical incision remains uncertain
SHEA
(June 2014)
I
Wash and clean skin around incision site. Use a dual agent skin
preparation containing alcohol, unless contraindications exist
CDC (Draft 2014) 1A
Perform intraoperative skin preparation with an appropriate antiseptic
agent. Use an antiseptic agent with alcohol, unless contraindicated.
Local preparation of 2% chlorhexidine isopropanol solution
1. Isopropanol: 62.7 % g/g
2. Chlorhexidin digluconate 18.8% g/g solution: 12.1 % g/g
3. Distilled water up to 100%
Chlohexidine gluconate 2% w/v 35ml
Distilled / cool boiled water 200ml
Ethanol 95% Up to 1 liter
Surgical hand and skin preparation
Page 57
Intervention steps
2. Surgical hand preparation
• Antimicrobial soap+water = 2 – 5
mins
• Alcohol-based = 1.5 – 3 mins
• Good technique is crucial !
• Nail-brushes not recommended
Surgical handrubbingtechnique
WHO MODIFIED FORMULATIONS
Formulation I
• Final concentrations: Ethanol 80 %
w/w, glycerol 0.725 % v/v, hydrogen
peroxide 0.125 % v/v.
Ingredients:
1. Ethanol (absolute), 800 g
2. H2O2 (3%), 4.17 ml
3. Glycerol (98%), 7.25 ml (or 7.25 x
1.26 = 9.135 g)
4. Top up to 1000 g with distilled or
boiled water
Formulation II
• Final concentrations:Isopropanol 75
% w/w, glycerol 0.725 % v/v,
hydrogen peroxide 0.125 % v/v.
Ingredients:
1. Isopropanol (absolute), 750 g
2. H2O2 (30%), 4.17 ml
3. Glycerol (98%), 7.25 ml (or 7.25 x
1.26 = 9.135 g)
4. Top up to 1000 g with distilled
water
Page 59
Handwashing quality score
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9
high low med
Inappropriate reprocessing of medical devices and surgical instruments
Washed under running water
Immersed in
2% glutaraldehyde for 8 - 10 hrs
Expert group on safe reprocessing of medical devices and sterilization
62
Mehtar Shaheen South Africa
Christina Bradley UK
Dianne Trudeau Canada
Lisa Huber USA
Nizam Damani UK/Pakistan
Oonagh Ryan UK
Thank you for your attention
For more information:
• Contact information
WHO SERVICE
DELIVERY AND SAFETY
• Web sites
http://www.who.int/patien
tsafety/en/
www.who.int/gpsc/5may
Semmelweis at ICPIC
www.icpic2013.com
2015Save the Date:
3rd ICPIC, 16-19 June 2015,
Geneva, Switzerland